Kornimate/medical-research-clean huggingface dataset:
an open label, multi-center, follow-on study examining the long-term safety and efficacy of insulin viaject™ in subjects with type 1 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: follow-on study to the viaject™ 06j study to evaluate the long-term safety and efficacy of viaject™ when used as prandial insulin in combination with lantus® in subjects with type 1 diabetes mellitus. the viaject™ 06j study is the efficacy and safety study for insulin viaject™ to demonstrate equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for viaject™ in comparison to human insulin


Eligibility criteria:
inclusion criteria: 1. completed the viaject™-06j protocol 2. informed consent must be obtained in writing for all subjects exclusion criteria: 1. history of frequent severe hypoglycemia within the prior six months which prevent study participation at the discretion of the investigator 2. history of known hypersensitivity to any of the components in the study medication 3. progressive disease likely to prove fatal 4. known significant hepatic disease or serum ast or alt values \> 3 x upper limit of normal or bilirubin levels \> 1.5 x upper limit of normal 5. severe complications of diabetes mellitus including a history or finding of stage iii or iv diabetic retinopathy (see appendix b), proteinuria \> 2+ by urine dipstick, serum creatinine of \>1.8 mg/dl for males or \>1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease, which has resulted in amputation or recent onset of chronic foot ulcers or claudication, or the recent, clinically documented loss a pedal pulse. 6. history of moderate to severe ketoacidosis within the 3 months preceding screening for the study 7. current drug or alcohol abuse, or a history which in the opinion of the investigator will impair subject safety or protocol compliance. 8. current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator 9. a sexually active woman of childbearing age not actively and consistently practicing birth control by using a medically accepted device or therapy or a woman intending to become pregnant during the study 10. abnormal ecg, safety lab or physical examination results which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe 11. a history of lack of compliance with medical instructions, recent drug or alcohol abuse, or other reasons which, in the opinion of the investigator, render the participation of the subject in the study to be inappropriate or unsafe
women's estrogen/progestin lipid lowering hormone atherosclerosis regression trial (well-hart)

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause

Summary: to determine the effects, in postmenopausal women, of hormone replacement therapy on progression/regression of coronary heart disease, as measured by quantitative angiography.

background: the trial was a logical extension of preceding observational and cross-sectional studies on estrogen replacement therapy. overall, the studies suggested a 50 percent reduction in risk of coronary heart disease in current estrogen users compared to non-users. in spite of such striking findings, most studies had been prone to a number of biases. one major criticism of observational studies had been that women receiving estrogen were generally healthier and more compliant than non-estrogen users. there was a very large body of observational data suggesting that the use of estrogen in postmenopausal women reduced coronary heart disease mortality by approximately 45 percent. at the same time, there had been some concern that replacement therapy increased the likelihood of uterine cancer and perhaps breast cancer as well, although it was generally accepted that this risk was probably significantly less than the benefits obtained from the reduction of coronary heart disease mortality. design narrative: randomized, double-blind, placebo-controlled. after baseline angiograms, patients were randomized to one of three arms: micronized 17-beta estradiol, 1 milligram per day; 17-beta estradiol plus medroxyprogesterone, 5 milligrams per day for twelve days per month; and placebo. subjects in all three arms received lipid-lowering therapy, low fat/low cholesterol diet, and the hmg-coa reductase inhibitor, pravastatin, in sufficient dosage to reduce low density lipoprotein (ldl) cholesterol levels below 130 mg/dl. the primary endpoint was progression/regression of coronary obstructive disease as measured by angiography, including the expert human panel and quantitative computer analysis. the secondary endpoint was carotid media-intima thickness determined by ultrasound. clinical measures included lipids, lipoproteins, apolipoproteins, estradiol and medroxyprogesterone levels, urinary prostanoid metabolites, and insulin/glucose metabolism. subjects were recruited at three centers with active coronary angiography units. several core facilities supported the study: a core lipid lab, a reproductive endocrine lab, the biostatistics lab (data coordinating center) and the angiographic imaging laboratory. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
postmenopausal women with angiographically-documented coronary disease. approximately 70 percent minority
leafix adhesion in healthy volunteers

Conditions: Adhesion

Summary: this study compares the adhesiveness of the 3m material to be used in the final design.

the material is taken from a ce marked stoma bag. strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. a force gauge will measure the peel force. this will be compared to previous testing on metal. participants will also be assessed and followed up for any adverse skin issues.

Eligibility criteria:
inclusion criteria: * healthy volunteers * not been in a trial in last 12 weeks * mild to no skin issues exclusion criteria: * any significant allergies * any allergies to skin adhesive * any medium to severe skin issues
ctcl directed therapy

Conditions: Lymphoma, T-Cell, Cutaneous

Summary: cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. mycosis fungoides (mf) is the most common type of cutaneous t-cell lymphoma (ctcl) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. the incidence of mf is about 1/100,000. skin lesions tend to appear before the diagnosis of ctcl is made by several years. early skin lesions may look like any dermatitis, eczema, or psoriasis, leading to delays in the diagnosis. inflammation secondary to bacterial infection is thought to contribute to the t-cell proliferation in this type of cutaneous t-cell lymphoma. antibiotic use for other purposes has shown to reduce the inflammation and size of lesions in ctcl patients. there has been limited studies with the use of antibiotics as direct treatment for this cancer. host immunity is important in decreasing cancer development and progression. imiquimod is a molecule that stimulates host immunity to reduce the progression of ctcl. there is strong evidence of clinical efficacy such that the national comprehensive cancer network (nccn) guidelines recommend imiquimod for ctcl. imiquimod is available in generic form, making it unlikely to be registered specifically for ctcl, despite its efficacy. additionally, imiquimod is considered a first line treatment according to national comprehensive cancer network (nccn) guidelines for the treatment of mycosis fungoides. there are currently no studies that have been published that address treating ctcl patients with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics, and 2) enhancing the host immune system to destroy cancer cells. our theory is if we treat patient with 14days of antibiotics and 30 days of imiquimod there will be significant reduction in skin lesions.


Eligibility criteria:
inclusion criteria: * patients age 30 - 89 years old * stages i to ii ctcl patients * normal renal function, cr ≤ 1.5 exclusion criteria: * aggressively progressing ctcl * active infection and/or concurrent malignancy * poor renal function (cr \> 1.5) * pregnancy (hcg serum +) * history of bone marrow suppression, mds, anemia (hemoglobin \< 8), thrombocytopenia (\< 50,000) or neutropenia (anc \< 1500) * chf, mi within last 6 months * endocarditis * allergies to imiquimod or doxycycline
does varenicline influence alcohol consumption in alcohol dependent individuals?

Conditions: Alcohol Dependence

Summary: the aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (european trade name: champix(r); us trade name: chantix(r)), can reduce alcohol consumption in alcohol dependent individuals.


Eligibility criteria:
inclusion criteria: 1. age: 30-70 years at screening 2. alcohol dependence according to dsm-iv (meeting ≥3 out of 7 criteria) 3. ≥ 20 heavy drinking days (men: ≥ 5 drinks/day, women: ≥4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days 4. participants must have signed the informed consent exclusion criteria: 1. subject to treatment of alcohol withdrawal within 30 days of study initiation 2. subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, ssris, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation 3. subject to treatment of depression within 3 months of study initiation 4. the continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted) 5. any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial 6. history of delirium tremens the last 5 years or any history of abstinence-induced seizures 7. laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values. 8. participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective. 9. any ongoing serious psychiatric or somatic disorder 10. any psychiatric axel i diagnoses (except for nicotine or alcohol dependence) 11. the concurrent use of illicit drugs based on urine-toxicity test 12. the need for detoxification 13. diabetes mellitus type 1 14. suicidal risk 15. homelessness 16. additional factors that implies to the investigator/physician that the participant will not be completing the study

Keywords: alcohol dependence nicotine dependence alcohol abuse varenicline champix chantix smoking drinking snuffing diary phosphatidyl ethanol peth
impact of augmented reality during robot-assisted radical prostatectomy

Conditions: Prostatic Neoplasm

Summary: accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (rarp). however, the nerve sparing approach is associated with higher rates of positive surgical margins (psm) at final pathology. augmented reality (ar) rarp was previously associated with a 10-15% reduction in the rates of psms in two retrospective series. however, prospective studies are needed to demonstrate clinical utility and to validate these technologies. the hypotheses of this study are that: 1) ar rarp reduces the rates of psms, if compared to standard approach; 2) ar rarp can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of psms will translate in greater oncological control of the disease.

this is a phase iii, monocentric, prospective trial in which patients will be randomized to ar rarp vs. standard approach (standard rarp). patient population is defined as: patients≥18 years old, untreated biopsy-proven adenocarcinoma of the prostate classified as european association of urology (eau) low or intermediate risk (psa≤20 ng/ml and ct≤2b and international society for urological pathology \[isup\] grade group≤iii), pre-operative international index of erectile function-5 (iief-5)≥20, no contraindications for multiparametric magnetic resonance imaging (mpmri). the primary objective of this study is to compare the rates of psms with ar rarp vs. standard rarp. secondary objectives are the rates of nerve sparing approaches and erectile function recovery at 3-, 6- and 12-months after surgery in ar rarp vs. standard rarp. subgroup analyses will tested for a specific subgroup of patients in which ar rarp should be particularly indicated. longer-term follow-up will also assess the percentages of biochemical recurrences (bcr) in the two groups.

Eligibility criteria:
inclusion criteria: untreated, biopsy-proven adenocarcinoma of the prostate age ≥18 years european association of urology (eau) low or intermediate risk prostate cancer: * psa≤20 ng/ml * ct≤2b * international society for urological pathology \[isup\] grade group≤iii written informed consent provided for participation in the trial international index of erectile function-5 (iief-5)≥20 no contraindications for multiparametric magnetic resonance imaging (mpmri) exclusion criteria: any prior therapy for prostate cancer european association of urology (eau) high risk prostate cancer: * psa\>20 ng/ml or * ct\>2b or * isup grade group\>iii international index of erectile function-5 (iief-5)\<20 prostate cancer with sarcomatoid or spindle cell or neuroendocrine small cell components morbidity that would limit compliance with study protocols controindications to perform mpmri
a study to evaluate the safety, tolerability and pharmacokinetics of hr011408 at two formulations in healthy subject

Conditions: Diabetes in Adults

Summary: the objective of the study is to assess the safety, tolerability and pharmacokinetics of hr011408 at two formulations in healthy subject.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18-55 years(both inclusive) at the time of signing informed consent 2. body mass index 18.0-26.0kg/m2(both inclusive) 3. body weight ≥50.0kg(male),≥45.0kg(female) 4. fasting serum/plasma glucose \<6.1mmol/l exclusion criteria: 1. known or suspected of being allergic to any ingredient in the study drug. 2. participated in any drug or medical device-related clinical trial within 3 months before screening. 3. subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration 4. donated blood within 1 month before screening; or donated blood ≥400 ml or had blood loss ≥400 ml during trauma or major surgery within 3 months before screening. 5. subjects with incompetence or language impairment, who cannot fully understand or participate in the study.
hematopoietic stem cell transplant for high risk hemoglobinopathies

Conditions: Sickle Cell Disease; Transfusion Dependent Alpha- or Beta- Thalassemia; Diamond Blackfan Anemia; Paroxysmal Nocturnal Hemoglobinuria; Glanzmann Thrombasthenia; Severe Congenital Neutropenia; Shwachman-Diamond Syndrome; Non-Malignant Hematologic Disorders

Summary: this is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell disease, thalassemia, diamond blackfan anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated * acceptable stem cell source identified * performance status of ≥ 70% (karnofsky),or ≥ 70 (lansky play score) * creatinine \ 50 ml/min for children * bilirubin, aspartate aminotransferase, alkaline phosphatase \<5 times the upper limit of institutional normal * absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40% exclusion criteria: * active, uncontrolled infection * pregnant or breastfeeding * hiv positive

Keywords: stem cell transplant
childhood acute lymphoblastic leukaemia: follow-up

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Summary: over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. after end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. however, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce. the aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (all), including symptoms and blood test results. further, we aim to evaluate if the mode of detection affects survival.

investigators have identified a cohort of children with b-precursor all and t-all enrolled in the nordic society of paediatric haematology and oncology (nopho) all-92, all-2000 and all-2008 trials and experienced a relapse or an smn as the first event after cessation of maintenance therapy (368 patients). from medical charts and blood test results it will be decided whether the relapse/smn was diagnosed at a routine visit (including routine blood tests) or if the relapse was diagnosed because of symptoms at a non-scheduled visit or blood test. as the nopho database probably is one of the most complete databases globally, it is an advantage to perform this study as a nopho study. results of this population based relapse study will provide an evidence-based background for planning optimal and relevant follow-up programs for children after therapy of all treated according to contemporary nordic all protocols. the study is important and relevant in the light of today's high all cure rates and a need for optimal follow-up programs after cessation of all treatment and possible prediction of relapse. the timing of the project is an increased focus on the clinical relevance of routine clinical follow-up of patients treated for cancer.

Eligibility criteria:
inclusion criteria: * diagnosed with pre-b or t-cell all in the nordic countries (denmark, sweden, norway, finland or iceland) * included in the nopho all-92, all-2000 or all-2008 trials * treated in a paediatric department * developing a relapse/smn after cessation of maintenance therapy before 31st of december 2016 exclusion criteria: * hematopoietic stem cell transplantation in first complete remission
evaluating the efficacy of topical insulin for the restoration of ocular surface interface in dry eye disease.

Conditions: Dry Eye; Insulin Sensitivity

Summary: this is a parallel randomized controlled trial for the treatment of dry eye disease. the main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. topical insulin drops will be compared to artificial tears in improving the ocular surface interface in patients with dry eye disease over 1 year period.

patients fulfilling the selection criteria will be enrolled from eye opd of kth. a written informed consent will be taken after explaining the purpose of study. data will be collected on a pre-designed structured proforma. demographic data including age, gender, educational status, socioeconomic status will be noted. each participant will undergo a complete history assessment and the osdi score will be calculated after taking extensive history. ophthalmologic examination, including visual acuity, refraction, slit-lamp examination, corneal staining, schirmer test and tbut will be performed in each patient. both eyes will be selected for each secondary outcome measure (tbut \& schirmer test). however, only one osdi score could only be obtained per patient for assessing primary outcome. all the previous medications used for dry eye will be stopped participants' eyes will be randomized by blocked randomization in a 1:1 ratio to be treated with topical artificial tears (group i) and topical insulin 1u/ml (group ii). the patients will be masked for the treatment, but not the principle investigator. another investigator will prepare the topical insulin according to a written protocol. participants will be given a white, unlabeled eye dropper containing the same volume of artificial tears or topical insulin for groups i and ii respectively. group i will receive artificial tears (control group) four times daily. group ii will receive topical insulin of 1u/ml four times daily. follow-up assessments will be conducted at 4, 8 and 12 weeks for each participant to measure changes in tbut, schirmer test, and osdi score.

Eligibility criteria:
inclusion criteria: * patients having schirmer's test values of less than 10mm after 5 minutes of the procedure recording plus a non-invasive tear breakup time (tbut) of less than 10 seconds and the ocular surface disease index (osdi) of more than 32 (diagnosed as dry eye disease as per the operational definition of this study). * any gender. * aged 18 years and above. exclusion criteria: * patients with active ocular infection, severe ocular surface disease other than dry eye disease, and those who have undergone ocular surgery within the past 6 months. * under 18 years old

Keywords: dry eye disease topical insulin ocular surface interface restoration